Laparoscopy Kit (FDE) contract manufacturers
13 US facilities list FDA product code FDE as a contract manufacturer (4) or contract sterilizer (9).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Laparoscopy Kit
- Product code
- FDE (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Classification panel
- Gastroenterology and urology
Where they are
Tennessee 4 · Texas 4 · California 1 · Georgia 1 · Illinois 1 · Missouri 1 · North Carolina 1
All 13 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1060680 | Contract manufacturer | General and plastic surgery; General hospital; Physical medicine +5 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 2320762 | Contract manufacturer | General and plastic surgery; General hospital; Gastroenterology and urology +7 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1643817 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Cardiovascular +14 more | El Paso, TX | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc | 3009888344 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; General hospital +13 more | El Paso, TX | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +14 more | Jackson, MO | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 3005012805 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Anesthesiology +12 more | Laredo, TX | Not verified | Oct 21, 2026 |
| PACKROOM LLC | 3008513424 | Contract manufacturer | Cardiovascular; General hospital; Obstetrics and gynecology +2 more | Mc Donough, GA | Not verified | Oct 21, 2026 |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 1418479 | Contract manufacturer | Gastroenterology and urology; Obstetrics and gynecology; Orthopedic +4 more | Vernon Hills, IL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1061124 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029015 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +13 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
Related gastroenterology and urology product codes
- GCJ Laparoscope, General & Plastic Surgery (96)
- KNW Instrument, Biopsy (69)
- KNT Tubes, Gastrointestinal (And Accessories) (47)
- FGE Stents, Drains And Dilators For The Biliary Ducts (30)
- FCG Biopsy Needle (27)
- NAY System, Surgical, Computer Controlled Instrument (25)
- KOD Catheter, Urological (24)
- EZL Catheter, Retention Type, Balloon (23)